The future of medical device development
The future of medical device development
The future of medical device development
Handle requirements & risk management, end-to-end traceability, and related compliance activities—all in one place.
Handle requirements & risk management, end-to-end traceability, and related compliance activities—all in one place.
Handle requirements & risk management, end-to-end traceability, and related compliance activities—all in one place.
Built and trusted by medtech innovators
Built and trusted by medtech innovators
Built and trusted by medtech innovators
We’re building the single source of truth for your product data
We’re building the single source of truth for your product data
Built for the velocity of modern med-tech product development
Built for the velocity of modern med-tech product development
○
Design Control
Multi-level requirements management. Fast filtering and search. Seamless generation of records. Best-in-class traceability.
○
Risk Management
Simple but powerful. ISO 14971 compliant. Traceability to Design Control.
○
Quality Management
Lightweight & configurable. ISO 13485 compliant. Documents, training, supplier management, quality events, and more.
Built for
product
engineering
quality
speed
product
engineering
quality
speed
product
engineering
quality
speed
product
engineering
quality
speed
A platform your engineers will actually use. A configurable QMS with sensible defaults.
Built for
product
engineering
quality
speed
product
engineering
quality
speed
product
engineering
quality
speed
product
engineering
quality
speed
A platform your engineers will actually use. A configurable QMS with sensible defaults.
○
Design Control
Multi-level requirements management. Fast filtering and search. Seamless generation of records. Best-in-class traceability.
Risk Management
Quality Management
Built for
product
engineering
quality
speed
product
engineering
quality
speed
product
engineering
quality
speed
product
engineering
quality
speed
A platform your engineers will actually use. A configurable QMS with sensible defaults.
○
Design Control
Multi-level requirements management. Fast filtering and search. Seamless generation of records. Best-in-class traceability.
Risk Management
Quality Management
○
Design Control
Multi-level requirements management. Fast filtering and search. Seamless generation of records. Best-in-class traceability.
Risk Management
Quality Management
The Ultralight Difference
The Ultralight
Difference
Do more with less
Save your team’s time for value add activities
Spend less money on expensive consultants
Design better products
Work within contextualized design tools built for engineers
Automatically document design data in an intuitive way
Ensure compliance
Leverage simplified regulatory frameworks
Implement an FDA / ISO compliant quality system